Syneos Healthยฎ, a global biopharmaceutical solutions organization, is hiring Regulatory Associate, Regulatory Consultant, and Senior Regulatory Associate professionals with EU market and CMC Module 3 experience. These roles are open for India (Remote โ Pre-Approved / Gurugram Hybrid) and focus on small molecule regulatory submissions, lifecycle management, and post-approval variations.
This is a strong opportunity for M.Pharm and life sciences professionals looking to build or advance a career in EU regulatory affairs, CTD Module 3 authoring, and EMA submissions.
๐ Available Positions
- Regulatory Associate โ EU Market (CMC Module 3)
- Regulatory Consultant โ EU Market (Module 3)
- Senior Regulatory Associate โ EU Market Experience
Job Type: Full-Time
Work Mode: Remote (Pre-Approved) / Hybrid (Gurugram)
Location: India
Company: Syneos Healthยฎ
๐งช Key Responsibilities (EU CMC Regulatory Affairs)
- Authoring and supporting CTD Module 3 (CMC) for small molecule products
- Preparation of MAA, IND, NDA, DMF, post-approval variations, renewals, and lifecycle management submissions
- Conduct regulatory gap analysis based on EU, GCC, and APAC guidelines
- Perform quality checks and compliance reviews of regulatory documents
- Support EMA regulatory submissions and agency interactions
- Maintain regulatory databases, records, and submission trackers
- Collaborate with cross-functional teams (CMC, QA, Clinical, PV)
- Assist in SOP development, audits, and regulatory intelligence activities
- Mentor junior team members (Senior roles)
๐ Eligibility & Qualifications
Regulatory Associate
- Experience: 6 months โ 2 years (internship experience preferred)
- Exposure to CMC Module 3 and EU regulatory framework
- Degree in Pharmacy / Life Sciences
Regulatory Consultant
- Experience: 4โ5 years in Regulatory Affairs
- Qualification: M.Pharm (preferred)
- Hands-on experience in CMC Module 3 authoring & post-approval variations
- Strong EU and GCC market exposure
Senior Regulatory Associate
- Experience: 2โ3 years in EU regulatory submissions
- Experience with Module 2 & 3 authoring, MAA & variations
- Ability to work independently on regulatory deliverables
Required Skills (All Roles)
- Strong knowledge of EU CMC regulatory requirements
- Excellent English communication & documentation skills
- Advanced MS Office proficiency
- High attention to detail and compliance mindset
- Ability to manage multiple regulatory projects simultaneously
๐ Why Join Syneos Health?
- Work on 95% of EMA-authorized products globally
- Exposure to top pharma & biotech clients
- Strong career progression & regulatory training programs
- Flexible remote & hybrid work model
- Inclusive Total Self culture
- Opportunity to work across EU, GCC & APAC markets
๐ฐ Salary (Estimated โ India)
- Regulatory Associate: โน4.5 โ 7 LPA
- Senior Regulatory Associate: โน7 โ 11 LPA
- Regulatory Consultant: โน12 โ 18 LPA
(Salary may vary based on experience, role, and project scope)
๐ How to Apply
Application Link For Regulatory Associate
Application Link For Regulatory Consultant
Application Link For Senior Regulatory Associate
